Protocol Submission Guidelines
STEP 1 IRB Submission
When starting a project that involves interacting with or collecting data about people (e.g. surveys, interviews, and or data collection), it is not always clear whether or not you are conducting human subjects research (HSR) which requires approval by the Institutional Review Board (IRB). All projects that involve human subjects must be vetted by the IRB to determine review before the project can begin. The Graduate School’s Office of Research & Projects has developed a screening method within the Kuali electronic protocol system which will help to determine if your project requires IRB review and approval.
You can see a full list of Common Rule definitions here, however, the IRB encourages completion of the screening tool for all projects involving interaction with or data collection about human subjects.
Complete this step and submit a protocol early because IRB determination and review may take multiple weeks. The following approximation timelines are provided but note that it is impossible to determine exactly how long a review will take:
- exempt review 1-3 weeks
- expedited review 3-6 weeks
- full board review 4-8 weeks or longer.
Note: exempt and expedited protocols are reviewed on a continuous rolling basis. Full board protocols are reviewed during IRB full board meetings which take place once a month. The deadline to submit a full board human subjects research IRB protocol to the IRB is always the 2 weeks before the second Wednesday of the month in which you would like for it to be considered.
STEP 2 Complete Required CITI Training
If the IRB Administrator determines your project requires IRB review, all investigators on the project are required to complete mandatory human subjects training before the IRB can approve the protocol. From the list of courses offered, choose one or more of the following:
- "IRB Social Behavioral Student"
- "IRB Social Behavioral Faculty"
- "Biomedical Researcher"
- "IRB Member"
STEP 3 Submit Your Protocol
Log into the Kuali Online IRB Protocol System to create and submit your protocol. An online tutorial is available as well as an IRB Protocol Guide.
Faculty may direct their students to the SandBox Practice Site to create protocols in the offline system for teaching purposes only. These protocols are not live and will NOT be reviewed by the IRB. This site will allow students, faculty, and staff to learn the system before submitting a protocol in Kuali Research for IRB review.
STEP 4 Insurance
If student-initiated (student PI) research is not being conducted as a part of a course or degree requirement, the student will need to obtain insurance and provide proof of that insurance to the Compliance Office prior to protocol approval.
The SIU Risk Management Office provides information regarding potential sources of insurance and the required coverage.
For questions, contact SIU Risk Management at riskmgmt@siu.edu or 618-536-3331.
STEP 5 Investigator Responsibilities Following IRB Approval
Investigators must carry out the research as specified in your approved IRB protocol. Log into the Kuali Online IRB Protocol System if the following occur:
-
You would like to propose changes to your approved project. These changes must be submitted to the IRB for approval before they are implemented. In the Kuali protocol, click “Amend” and describe your changes in the Justification section and make other necessary changes within the protocol. Submit these changes to the IRB for review and approval.
-
You were instructed by the IRB to submit an annual report.
-
You were instructed by the IRB to submit a completion report.
STEP 6 Other items
Unanticipated Problems and/or Serious Adverse Events must be reported to the IRB in a timely manner by contacting the IRB by phone at 618-650-3010 or email at researchcompliance@siue.edu.
